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Caris Life Sciences · 3 weeks ago

Process Quality Engineer

Phoenix, AZ

Full-time

Onsite

Entry, Mid Level

2+ years exp

Caris Life Sciences is transforming cancer care through precision medicine and innovative technologies. The Process Quality Engineer is responsible for ensuring ongoing product quality through process monitoring, statistical analysis, and quality improvement initiatives, collaborating with various stakeholders to address quality issues.

Artificial Intelligence (AI)BiopharmaBiotechnologyHealth CareLife Science

Responsibilities

Work closely with operations and the business functions to ensure quality performance of product and processes

Collaborates with Divisional QA, cross-functional groups, and supplier teams to address quality issues

Support implementation and/or verification of material and/or equipment specifications

Reviews incoming inventory material receiving records, and quality control testing documentation to release the materials for production use

Accountable for Material and Product releases through review and release of kit manufacturing and batch manufacturing records

Support execution of PFMEA, DFMEA and SOP generation associated with design transfers and product launch

Support execution and analysis of manufacturing related complaints and product field actions

Execute internal quality deliverables associated with operational changes, manufacturing transfers and supplier-initiated changes

Participates and may lead change control management; creation and/or review of new or modified procedures

Maintain KPIs for monitoring of process and/or product quality, perform analysis, and interpret trends, identifying and activating appropriate actions as necessary

Own or support identified internal NCs, Deviations, Quality events, CAPAs, and manage to timely root cause investigation, implementation and closure

Work to introduce and implement Six sigma, process improvement, statistical and problem-solving tools and methodologies

Support the development and review of production processes and for feedback through Measurement System Analysis (MSA) using DMAIC and tools

Applies statistical methods of analysis and process control to current operations

Develop understanding of risk management practices and concepts and applies knowledge to manufacturing operations

Responsible for initiation, internal containment, communication, and support of Commercial Holds for potential product escapes

Ensure adherence to GMP and safety procedures

Qualification

Quality assurance principlesStatistical analysisProcess improvementSix SigmaFDA regulationsInterpersonal skillsOral communicationWritten communication

Required

Bachelor's degree in engineering/science or related discipline with 2+ years' experience in a regulated environment OR High School diploma with 5+ years of experience in a regulated environment

Demonstrated knowledge of quality assurance principles

Demonstrated knowledge of improvement and statistical tools/methods used within process excellence activities

Good knowledge of quality control and monitoring methodologies

Experience in executing problem solving techniques related to manufacturing/design technical issues

Proven ability to drive and develop improvement of critical business metrics

Preferred

High School Diploma with 8+ years' experience in a regulated environment, or Bachelors degree with 5+ years' experience, or Master's Degree with 2+ years' experience

A minimum of 2 years of experience working within FDA regulated (Medical Device, Pharmaceutical) highly preferred and/or regulated industries (Automotive, Aerospace) preferred

Experience in change management, as well as ensuring assets are appropriately addressed to remain in a validated state

A Green Belt Certification in Six Sigma or similar certification preferred

Demonstrated organizational, interpersonal, oral and written skills